We are asked patients to take part in this study because they had recurrent (returned) (1st or 2nd) anaplastic astrocytoma (AA) or glioblastoma multiforme (GBM).

The purposes of this study are:

To see if Sutent has any change on the patient and their cancer.

To see if Sutent will slow or stop the growth of their tumor.

To measure the safety of Sutent. Sutent is Food and Drug Administration (FDA) approved to treat patients with a gastrointestinal stromal tumor after the disease worsened while taking another medicine called imatinib mesylate or when imatinib mesylate cannot be taken. Sutent is also FDA approved to treat patients with advanced renal cell carcinoma. At this time, it is not known whether Sutent will improve symptoms, or help patients with this disease live longer.

Complete Response: Disappearance of all lesions, disease signs and symptoms related to the tumor. Partial Response (PR): When compared with pretreatment measurements, a reduction of 50% decrease in the sum of the longest diameters of all target enhancing lesions, taking as reference the baseline sum of the longest diameter. Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since treatment started. Objective Progression or Relapse: Relative to pretreatment measurements, an increase in the sum of the diameters of any measured enhancing lesion by at least 25% increase in the sum of the longest diameters since the treatment started or the appearance of new enhancing lesions.

Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.

Drug: Sunitinib Malate

Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study.

Other Names:

Sutent

SU011248

Detailed Description:

Trial patients received sunitinib 50 mg daily for 4 weeks without regard to meals, followed by a 2-week rest period. This 6-week regimen constituted 1 cycle. Patients were treated for up to 9 cycles [~ year) or until disease progression or death or if persistent toxicities occurred. Complete blood count with differential, complete metabolic profile, neurologic exam, and brain magnetic resonance imaging (MRI) with contrast were obtained after each cycle. Toxicity assessments were obtained after each cycle. Toxicity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0.

Must sign and date an Institutional Review Board (IRB) approved informed consent stating that he or she is aware of the neoplastic nature of the disease. Must willingly provide written consent after being informed of procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.

Willing and able to comply with scheduled visits, treatment plan, laboratory tests and accessible for follow-up.

Have undergone surgery documenting tumor histology though repeat surgery at time of tumor recurrence is not mandatory.

Have received prior external beam radiotherapy.

Patients may have received one or two prior salvage chemotherapy and may have received adjuvant chemotherapy following initial surgery.

May not have received prior stereotactic radiotherapy.

May have been treated with Gliadel at initial surgery only.

Exclusion Criteria:

Major surgery or radiation therapy within 4 weeks of starting study treatment.

Concomitant use of ketoconazole and other agents known to inhibit Cytochrome P450 3A4 (CYP3A4).

Concomitant use of theophylline and phenobarbital and/or other agents metabolized by the cytochrome P450 system.

Ongoing treatment with therapeutic doses of Coumadin (low dose up to 2 mg po daily for thrombo-prophylaxis is allowed).

Pregnancy or breastfeeding. Female subjects must be surgically sterile, postmenopausal, or must agree to use effective contraception during the period of therapy. Female subjects with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy.

Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with interpretation of study results, and in the judgment of investigator would make patient inappropriate for entry into this study.

Patients having been treated with 3 or more salvage regimens.

Patients with a second active malignancy or diagnosis of other cancer within 3 years of enrollment, except for surgically cured basal cell carcinoma, or in situ carcinoma of the cervix.

Mentally incapacitated patients or psychiatric illness that would prevent them from giving informed consent.

Patients with an active infection that is not adequately controlled with antibiotics.

Patients with other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Known sensitivity to any of the products to be administered during treatment.

Currently enrolled in another clinical trial or patients who have participated in a trial of an investigational device or drug within the last 30 days.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606008